Probiotics for the Oncological Patients

Project Information

ONCOTICS

Grant agreement ID: 817071

DOI

10.3030/817071

Project closed

EC signature date 9 May 2018

Start date 1 June 2018

End date 30 November 2018

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

PHARMACEUTICAL BIOTECHNOLOGY SRO
Czechia

Periodic Reporting for period 1 - ONCOTICS (Probiotics for the Oncological Patients)

Reporting period: 2018-06-01 to 2018-11-30

Summary of the context and overall objectives of the project

The increase in oncological diseases is exponential. The reasons are not fully known, however, national cancer registries of all EU countries report a higher and higher number of oncology patients each year. Even though the oncology treatment has made significant progress in recent years, the novel methods bring a number of side effects that may be even life-threatening in many cases. One of these side effects includes loss of intestinal mucosa integrity, dysbiosis, inflammatory processes in the intestine and prolonged diarrhoea or congestion, on the contrary.

In this context, Pharmaceutical Biotechnology introduces the novel the unique product, which brings into the market breakthrough solution for oncology patients – ONCOTICS. Our solution is based on the newly developed (and ready to be patented), very gentle form of microbial lysis which preserves the biologically active molecules of probiotic bacteria that favourably affects the cells of the intestinal mucosa and the mucosal immune system.
These newly designed probiotics modify the integrity of the intestinal mucosa damaged as a result of oncological treatment, to suppress inflammatory changes in the mucous membrane and, at the same time, to contribute to stabilization by the treatment of the disrupted microbiome.

The ONCOTICS introduces novel treatment of intestines infections which brings :
o Unique probiotic lysates product improving the oncology patients life comfort
oA neww approach for elimination of leaky gut syndrome by oncological patients
o Very safe gut barrier regeneration compared with standard probiotics, which can cause sepsis
o New patented technology for production of probiotics lysates
o Novel therapy opening new markets
The objective of the SME Instruments Phase I project was to prove the technical and commercial viability of the product and to gain more detailed overview of potential market and distribution channels.
The final product has high potential to improve the quality of life of oncology patients and eliminate the chemotherapy side-effects. Even though the oncology patients are the main target group of users, the product might be further optimized for other illnesses.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The Feasibility study was divided into two main parts, the commercial viability, and the technical viability, both with the same importance. The detailed market analysis confirmed the exponential growth of new oncology cases - the potential ONCOTICS users. Contrarily, none of the state of the art solutions is able to solve the chemotherapy side-effects, as the intestinal mucosa damage and other gastroenteric diseases consequently. As the freedom to operate for both technology and product was confirmed, the ONCOTICS has the potential to become the unique product on the market, without any direct competitor and in very acceptable price, both in EU and US market.

The technical feasibility was confirmed by the series of experiments, focused on the probiotic cells processing and the confirmation of the pretests were performed. The methodology of higher technical efficiency was confirmed, as well as the ability of the new product to prolong the life time of gut mucosa cells, which is crucial especially during the radiotherapy or chemotherapy. Finally, the protective properties of ONCOTICS against the tissue demage was confirmed.

For the market success, the key factor is also technology utilization. The technology was transferred from the laboratory to the production matter and PB is currently capable to ensure the commercial production of the product. However, for the massive usage the preclinical and clinical testing will be necessary to certify the product as the medical drug. In parallel, we actively fulfilled general conditions for ONCOTICS to be accepted as the food supplement.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Currently, probiotic supplementation of oncology patients is being treated very cautiously in ongoing treatment. In some cases, probiotic supplementation in a patient attenuated by treatment has caused a strong infection and required subsequent treatment or caused death. The greatest risk includes living probiotic bacteria that, in rare cases, may cause sepsis in a weakened patient. As a result, physicians maintain caution and distance from using probiotic cultures to deal with diarrheal diseases during ongoing chemotherapy or radiotherapy.

Our approach allows probiotic supplementation of oncology patients in a completely safe form with no risk of life threatening sepsis. The main advantage is the possibility of live probiotic processing by dry lysis technology which we developed, where the cells of probiotic bacteria after lyophilization are disrupted and decomposed in
a careful and controlled manner. Thus, a number of active components are released from the cells, which have a very positive effect on the mucosal immunity and the overall regeneration of the intestinal mucosa. At the same time, the components released from lysed probiotic bacteria specifically inhibit the potential microbial
origin of diarrhea. Our technology represents a unique process of so-called Dry lysis, which allows us to safely disturb probiotic bacteria without thermal denaturation during the process. This makes it unique to preserve the biological activity of the active molecules obtained from probiotic bacteria. Molecules released from disrupted probiotic bacteria then act to restore the intestinal mucosa and supression of pathogenic bacteria propagation by a number of molecules. Probiotic lysates, which will retain the native structure of the individual components thus obtained, can absolutely fulfill the same function as the live bacteria. On the contrary, due to the release of biologically active molecules, they can act better in the short term than live bacteria.

The newly developed ONCOTICS product will allow long-term and safe supplementation of oncology patients during treatment. We will reduce the risk of diarrhea development or reduce the intensity of this side effect of existing oncology treatment. We will relieve patients of disturbing frustrating conditions when they have to spend a part of the therapy by permanent stress from diarrhea, dehydration, and exhaustion. Any limitation of these conditions has two baselines of help:

· The humane level: reduction of pain, exhaustion and psychological harm due to undesirable effects of treatment.
· Economical savings: any limitation or reduction of side effects will normally lead to lower costs spent on treating these side effects.

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